Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos
研究概览
简要总结
Blow-out fractures result from direct blunt impacts to the orbit which causes an immediate rise increase in intra-orbital pressure. Decompression via fracture of the orbital floor then occurs. Motor vehicle accidents are the main cause of orbital trauma. Also, industrial accidents, sports-related facial trauma, and assaults are important causes.
Clinical manifestations include ecchymosis, limitation of eye movements resulting in diplopia, enophthalmos. Very rarely, severe pain and nausea immediately after the injury are reported.
Radiologic evaluation including computed tomography (CT), plane radiology and magnetic resonance imaging (MRI) are the mainstay diagnostic modalities used for evaluation of cases with orbital trauma.
Treatment of the orbital blow-out fractures is aimed at restoring floor continuity, thus providing adequate support for orbital contents preventing their herniation and incarceration, thereby possible subsequent fibrosis of soft tissues most importantly extraocular muscles.
Various alloplastic or autogenous grafts are used for reconstruction of orbital blow-out fractures.
详细描述
A prospective interventional randomized controlled study, including 80 patients (who presented at trauma unit in Assiut university hospital between May 2020 to May 2023 and fulfilled the inclusion criteria) was conducted. Patients with orbital floor blow-out fractures were selected irrespective of their age and gender. The study followed the tenets of the Helsinki declaration and guidelines of the local research committee. An informed written consent was signed by all the patients who agreed to be enrolled in the study, or their relatives if consciously disturbed patients. All operations were done within 2 weeks of the trauma.
Patients were divided into 2 groups:
- Group I (40 patients) consists of immediate surgical reconstruction of pure orbital floor blow-out fractures by titanium mesh.
- Group II (40 patients) consists of immediate surgical reconstruction of pure orbital floor blow-out fractures by autogenous iliac graft.
Inclusion criteria:
Clinical Enophthalmos, diplopia, and/or limited ocular motility in one or more directions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Enophthalmos, diplopia, and/or limited ocular motility in one or more directions.
- •Radiological:
- •- CT scan (axial, coronal & 3 dimensional): Fracture of the orbital floor with herniation of the orbital contents (extra-ocular muscles, or orbital fat)
排除标准
- •patients with bilateral orbital fractures or severe facial fractures.
- •Patients with bad general condition or uncontrolled diabetes mellitus.
研究组 & 干预措施
Patients with orbital blow-out fractures
Treated by immediate surgical reconstruction of orbital floor blow-out fractures by titanium mesh (within 2 week of the trauma)
干预措施: Titanium mesh (Procedure)
Patients with orbital blow-out fractures were selected irrespective of their age and gender
Treated by immediate reconstruction of orbital floor by autogenous iliac graft (within 2 week of the trauma)
干预措施: autogenous iliac graft (Procedure)
结局指标
主要结局
Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos
时间窗: 1 year
CDVA expressed as decimal notation using a chart projector utilizing built in Snellen's charts. Also, ocular motility examination in the six cardinal positions of eye movements was carried out to document any limitation of eye movement (direction and degree). Moreover, Hertel's exophthalmometer was used to measure the degree of enophthalmos.
次要结局
未报告次要终点
研究者
Menatallah Gamal Saleh
lecturer of ophthalmology
Assiut University